Implantable drainage device

ABSTRACT

An implantable drainage device is provided. The device is adapted to move body fluid from one part of the body of a patient to another part of the body.

This application is the U.S. national phase of International ApplicationNo. PCT/SE2009/000037, filed 28 Jan. 2009, which designated the U.S. andclaims the benefit of U.S. Provisional No. 61/006,711, filed 28 Jan.2008, the entire contents of each of which are hereby incorporated byreference.

TECHNICAL FIELD

The present invention relates to a method and a device for draining bodyfluid.

BACKGROUND

Body fluid drains are used at so-called drainage sites for drainingfluids from cavities in a patient's body, typically during and aftersurgical procedures. The drainage site may be a natural body cavity ororifice or may be surgically formed.

The drain device used for draining fluid from the body typicallycomprises a tube extending from the treatment area within the bodythrough the skin of the patient and ending in a manual pump locatedoutside the body. The pump is associated with a reservoir for storingthe drained fluid. The reservoir is then emptied at suitable timeintervals by manually compressing the reservoir.

A drain can be required for shorter or longer periods of time dependingon the condition for which the drain is used. In particular when thedrain is used for a longer period of time the drains existing today arecumbersome to use and impractical for the patient who is required tomove the drain with him/her when moving around.

Also, U.S. Pat. No. 7,195,608 describes a drainage device for movingfluid to the urine bladder.

Hence, there exists a need for a drain that is less cumbersome to useand which enables a patient to more easily move around while still beingattached to the drain.

SUMMARY

It is an object of the present invention to overcome or at least reducesome of the problems associated existing drainage devices

It is another object of the present invention to provide a drainagedevice that enables a patient to more easily move around while stillbeing attached to the drain.

It is yet another object to provide a drainage device that is moreuser-friendly and which does not require manual monitoring.

These objects and others are obtained by the method, apparatus, deviceand system as set out in the appended claims. Thus, by providing animplantable drain adapted to move body fluid from one part of the bodyto another part of the body, a drainage device that which is completelyimplanted and which does not have any mechanical structure penetratingthrough the skin of the patient is obtained.

The apparatus for drainage of a body fluid in a human or mammal patientin accordance with the present invention comprises a drainage device forpumping body fluid. The drainage device is powered by an energy sourceand may be powered by any suitable means such as an electrical or ahydraulic motor. At least one connecting tube is connected to thedrainage device so that the drainage device and the tube form a drainagearrangement. The drainage arrangement is adapted to be implanted insidethe body of the patient, and placed so that the tube interconnects onepart of the body with another part of the body and where drainage deviceis adapted to suck body fluid from the one part of the body via the tubeto the other part of the body. Hereby an implantable drainage device isobtained which can pump body fluid from a treatment area to another partof the body where the fluid can be absorbed and transported out from thebody in a normal way.

In accordance with one embodiment a drainage device is provided with apump comprising a bellow having an inlet with an inlet return valve andan outlet with an outlet return valve. In addition a spring may beadapted to move the bellow to expand to suck from the inlet, and a motormay be adapted to compress the bellow and move fluid out via the outletthereby pre-tensioning the spring. The motor is advantageously adaptedto repeat the compression at suitable time intervals whereby thedrainage device is enabled to repeat the sucking and moving of fluid tosubstantially constantly suck fluid when not moving fluid to the otherpart of the body. In one embodiment of the present invention the motoris adapted to compress and decompress the bellow with or without the useof a spring force in a repeated pattern. Hereby a substantially constantdrain of the drained area is obtained without any manual interaction.

The implantable drainage device in accordance with the present inventioncan be used to move body fluid between different parts of the bodydepending on the type of body fluid being drained. For example andwithout limitation the drainage device can be adapted to drain urinefrom the urine accumulating renal part of the kidney, and moving theurine via at least one tube to the urine bladder. The drainage devicecan also be adapted to drain liquid from the hydrocephalus in the brainarea, and moving it to the abdomen. The drainage device can also beadapted to drain liquid from ascites in the abdomen, and moving it tothe lymphatic system of the body. Also, the drainage device can also beadapted to drain liquid from the thoraxial cavity, and moving the liquidto the abdomen.

Depending on the type of treatment and where the body fluid is suckedfrom and to where in the body the fluid is delivered the tubes used maybe shaped to suit the particular treatment.

The motor powering the drainage device can be provided with an energysource that is chargeable from outside the body. For example, the energysource of the motor may comprise an internal energy source and externalenergy source transmitting wireless energy and further comprising anenergy transmitter transmitting wireless energy from the external energysource to charge said internal energy source. The energy can betransferred to the internal energy source for example by inductivemanner using a coil. Energy can also be transferred using anon-inductive mechanism such as via ultra sound or by way of light.Hereby there is no need for surgery when the energy source of the motorneeds to be recharged. In addition the apparatus can further be adaptedto send feedback information from inside the body to the outside thereofto give feed back related to any functional parameter of the device or aphysical parameter of the patient. The functional and or physicalparameter(s) of the device can be correlated to the transfer of energyfor charging the internal energy source whereby the energy transfer canbe regulated. Also the drainage device can be adapted to non-invasivelyhave any of its functions regulated by an energy transmitter

In order to prevent or remove a possible occlusion in the tube thedrainage device can be provided with a backward release member adaptedto generate a backward pressure of fluid or air in the tube for removingor preventing a possible occlusion in the tube. The backward pressure ispreferably repeatedly according to a predetermined time schedule. Inaccordance with one embodiment the release member comprises apre-pressurized reservoir of air and a valve adapted to release a puffof air in the tube. In accordance with another embodiment the pump isadapted to move fluid or air in the tube in the reversed directionthereby creating a reverse flow for prevent or remove a possibleocclusion in the tube. In accordance with yet another embodiment areservoir of the drainage is pre-pressurized by the pump, and a valve ofthe device is adapted to release a puff of fluid or air in the tubeextending from the pre-pressurized reservoir when the pressure hasreached a predetermined level.

The implantable device in accordance with the present invention can beplaced within the body of a patient at a suitable location depending onthe particular treatment. For example and without limitation theimplantable drainage device may be placed subcutaneously via surgery orbe placed in the abdomen.

In accordance with one embodiment the drain device comprises asubcutaneous switch, which is adapted to manually and non-invasivelycontrol any function of the drainage device. In accordance with anotherembodiment the further comprises a hydraulic device, comprising ahydraulic reservoir, wherein the drainage device is adapted tonon-invasively be regulated by manually pressing the reservoir. In yetanother embodiment the device comprises a wireless remote control,wherein the drainage device is adapted to non-invasively have any of itsfunctions regulated by the remote control.

In accordance with one embodiment the device according to the presentinvention may be provided with a sensor sensing a physical parameter ofthe patient and/or a sensor sensing a functional parameter of thedrainage device. Also there may be provided an internal control unitacting in response to a sensor sending information. In one embodimentthe sensor is a pressure sensor. The control unit may provide controlsignals to an operation device which acts to move fluid within thedrainage.

The device according to the present invention can be regulated invarious ways. For example any function of the device is regulated fromoutside the human or mammal body. In accordance with one embodiment theregulation is performed by manually pressing a subcutaneous switch or areservoir or using a remote control or using an energy transmitter.

The invention also extends to a method of implanting and operating thedevice. The method comprises the steps of:

-   -   implanting a source of energy in the patient,    -   providing an external source of energy,    -   controlling the external source of energy to release wireless        energy,    -   charging non-invasively the implanted source of energy with the        wireless energy,    -   controlling the implanted source of energy from outside the        patient's body, and    -   releasing energy for use in connection with the operation of the        drainage device.

The method may additionally comprise the steps of

placing at least one connecting tube connected to said drainage devicein the specific treatment area in the human or mammal body,

sucking body fluid from one part of the body, through the tube,

supplying energy to said drainage device from said energy source, and

moving fluid to another part of the body, using power from said energysource

The present invention also extends to an operation method for surgicallyimplanting the device in accordance with the present invention in apatient, comprising the steps of:

cutting the skin,

dissecting a treatment area

dissecting a placement area

placing the drainage device in the placement area, and

placing the tube leading from the placement area to the treatment area

In accordance with a method for treating a patient needing drainage ofan area in the body, the following steps may be performed;

cutting an opening in the abdominal wall

dissecting the at least two intended areas

placing a drainage device and at least one tube in the dissected areas

suturing the abdominal wall.

In accordance with a method for implanting a drainage device thefollowing steps may be performed:

inserting a needle like tube into the abdomen of the patients body,

using the tube to fill the abdomen with gas thereby expanding theabdominal cavity,

placing at least two laparoscopic trocars in the patient's body,

inserting a camera through one of the trocars into the abdomen,

inserting at least one dissecting tool through a trocar and dissectingat two intended areas of

the patient,

placing at least one drainage device in the abdomen.

In accordance with a method for implanting a drainage device thefollowing steps may be performed:

cutting the skin,

dissecting an area around the renal part of the kidney area

dissecting a placement area where to place an implantable drainagedevice inside the

abdomen or retroperitoneal or subcutaneously

dissecting a delivery area around the urine bladder

placing the implantable drainage device in the placement area

placing a tube leading from the placement area to the renal kidney

placing a second tube leading from the placement area to the urinebladder.

In accordance with a method for implanting a drainage device thefollowing steps may be performed:

cutting the skin,

dissecting an area in the brain

dissecting a placement area where to place an implantable drainagedevice inside the

abdomen or retroperitoneal or subcutaneously

dissecting a delivery area in the abdomen

placing the implantable drainage device in the placement area

placing a tube leading from the placement area to the brain

placing a second tube leading from the placement area to the abdomen.

In accordance with a method for implanting a drainage device thefollowing steps may be performed:

cutting the skin,

dissecting an area in the abdomen

dissecting a placement area where to place an implantable drainagedevice inside the

abdomen or retroperitoneal or subcutaneously

dissecting a delivery area around the lymphatic system

placing the implantable drainage device in the placement area

placing the tube leading from the placement area to the abdomen

placing a second tube leading from the placement area to the lymphaticsystem.

In accordance with a method for implanting a drainage device thefollowing steps may be performed:

cutting the skin,

dissecting an area in the thorax

dissecting a placement area where to place an implantable drainagedevice inside the

abdomen or thorax or retroperitoneal or subcutaneously

dissecting a delivery in around the abdomen

placing the implantable drainage device in the placement area

placing the tube leading from the placement area to the thorax

placing a second tube leading from the placement area to the abdomen.

In accordance with one embodiment a method of securing a connecting tubefor use in an implantable device is provided. The tube is adapted tomove body fluid from one part of the body, via the at least oneconnecting tube to another part of the body, the connecting tube havinga distal end adapted to be located in the bladder of the human or mammalpatient for drainage of a body fluid from a treatment area of the humanor mammal patient into the bladder, the method comprising the steps of:

-   -   opening a hole in the bladder,    -   placing the end of the tube in the bladder.    -   securing the tube on the outside of the bladder by invaginating        the tube using sutures or staples, thus creating a tunnel around        the tube, wherein said tube comprising a net material secured to        said tube, the further method comprising,        placing the net material in connection to the opening of the        invaginated tunnel, and securing the net material to the outside        of the bladder.

The bladder can be the urine bladder or the peritoneum. The same methodcan also be used for securely fastening a tube into other organs.

In accordance with one embodiment a tube adapted to be inserted in aluminal or bladder organ of a patient, said tube adapted to enter saidorgan in a tube passageway. The tube comprises a combined securing andsealing device adapted for long term closing of the tube passageway andfor long term securing the tube onto an organ. The combined securing andsealing device can comprise a patch comprising a net mounted onto thetube. The net can be adapted to a seal of overgrowth of human fibrotictissue over the whole net and the patched part of said organ, therebycompletely sealing said net and attaching said net to said organ, thussealing around said tubular passageway. In accordance with oneembodiment a net structure is provide with openings less than 2.5 mm,preferable 0.5 mm, to allow said tissue overgrowth.

According to one embodiment there is provided a cleaning device forremoving clots and particles from the fluid passing through the drainagedevice. In accordance with one embodiment there is also provided acleaning device for cleaning the filter. One possibility is to clean thefilter mechanically.

The cleaning device preferably is adapted to move particles away fromthe passageway to a place free inside the patient's body, where the bodyitself will take care of the particles, such as clots.

Alternatively, a collecting volume, such as a bag, is provided forcollecting particles that have been mechanically cleaned from thefilter. Most likely such a bag will then be placed inside the body.

In a preferred embodiment, the cleaning device is adapted to slice, pushor scratch away any particles from the filter, but the cleaning devicecan also suck away any particles from the filter.

In one embodiment, the cleaning device comprises a first piston, withpreferably is provided with a first recess in an outer end portionthereof to collect particles and clots removed from the filter. Byproviding the first piston with a plurality of channels foraccommodating the filter in an extended position of the first piston, itcan surround the filter, ensuring essentially complete removal ofparticles therefrom. This is preferably performed if the first piston ismovable in a direction perpendicular to the direction of the flowpassageway.

The movement of the first piston can be controlled by a source ofpressurized air, ensuring rapid acceleration of the first piston andthereby short cleaning cycles. The movement of the first piston canalternatively be controlled by an electric motor, a solenoid or thelike.

The filter can in one embodiment be made of biocompatible material inorder to avoid unnecessary interference with the environment.

In one embodiment, a second piston is provided across the flowpassageway from the first piston, wherein the second piston is movablein a direction essentially perpendicular to the direction of the flowpassageway and spring biased in the direction of the first piston. If anouter end portion of the second piston is provided with a second recess,the first piston and the second piston cooperate to catch particles forfurther removal. This further removal can be accomplished by means of athird piston, which is movable in a direction perpendicular to both thedirection of the flow passageway and the direction of movement of thefirst piston and of the second piston.

In a preferred embodiment, the flow passageway of the cleaning devicehas an essentially square cross-sectional shape, which provides for alaminated flow, particularly if the square shape is combined with afilter comprising parallel strips.

The system can comprise a switch, preferably a subcutaneous switch beingadapted to manually and non-invasively control any function of thecleaning device.

According to one embodiment there is provided a filter for removingclots and particles from the fluid passing through the drainage device.The filter can be powered by a suitable energy supply thereby providingan active filter. In accordance with one embodiment there is provided apowered cleaning device for cleaning the filter. One possibility is toclean the filter mechanically. In accordance with one embodiment theactive filter is obtained by periodically changing the filter. Thefilter can be powered by any suitable energy source. In particular thesame energy source used for the pump used for moving fluid through thedrainage device can be used to power the active filter. By providing anactive filter the filter can be cleaned a suitable times therebyreducing the risk that the filter will be clogged. The way of achievinga clean filter can either be by cleaning the filter while in place or bycleaning it while not in position. If the filter is cleaned while not inposition in the fluid passageway of the drain, the drain can either bestopped while cleaning the filter or by replacing the filter withanother filter.

In one embodiment a cassette of filter is provided. When a filter risksbeing clogged, the filter is replaced by another filter in the cassette.The used filter can then either be disposed of or be cleaned for laterreuse.

In one embodiment the cassette is formed by a revolving cylindercomprising a number of filters. When the cylinder revolves on step a newfilter is placed in the passageway of the drain.

The cleaning device preferably is adapted to move particles away fromthe passageway to a place free inside the patient's body, where the bodyitself will take care of the particles/clots.

The system for removing particles preferably comprises a hydraulicdevice having a hydraulic reservoir, wherein the cleaning device isadapted to non-invasively be regulated by manually pressing thehydraulic reservoir.

A wireless remote control can non-invasively regulate any function ofthe cleaning device.

Even more important any function of the device may be programmable bysuch a remote control.

Also, a wireless energy transmitter can non-invasively energize thecleaning device. In one embodiment the same energy source is used forthe pump of the drainage device and to power the cleaning device.

The system preferably comprises a feedback device for sendinginformation from inside the patient's body to the outside thereof togive feedback information related to at least one functional parameterof the device or a physical parameter of the patient, thereby optimizingthe performance of the system. One preferred functional parameter of thedevice is correlated to the transfer of energy for charging the internalenergy source.

The system preferably comprises an operation device for operating thecleaning device. This operation device can comprise a motor or a pump,an electrically powered operation device, a hydraulic operation device,or an electric motor.

To improve the performance of the system for removing particles, aphysical parameter sensor, such as a pressure sensor, is provided forsensing a physical parameter of the patient. An internal control unitcan act in response to the physical parameter sensed by the sensor.

A functional parameter sensor sensing a functional parameter of thecleaning device can also be provided. An internal control unit acting inresponse to the functional parameter sensed by the sensor can also beprovided.

A method of using the system is also provided, wherein at least onefunction of the cleaning device is regulated from outside the patient'sbody. The regulation is in a preferred embodiment non-invasively bymanually pressing a subcutaneous switch. In an alternative embodiment,non-invasively regulation is performed by manually pressing a hydraulicreservoir connected to the cleaning device.

Alternatively, the cleaning system comprises a wireless remote control,wherein non-invasively regulation is performed using said remotecontrol.

In a preferred embodiment, the cleaning system for removing particlescomprises a wireless energy transmitter, wherein non-invasivelyregulation is performed using said energy transmitter.

Preferably, an energy source is used for powering and adjusting anyfunction of the cleaning device. The energy source may comprise aninternal energy source, which preferably is associated with an externalenergy source adapted to transmit wireless energy. Energy is preferablytransmitted from the external energy source to charge the internalenergy source. Feedback information is preferably sent from inside thebody to the outside thereof to give feedback related to the functionalparameters of the device or physical parameters of the patient. Thefunctional parameter of the device is correlated to the transfer ofenergy for charging the internal energy source.

In one embodiment, wireless energy is transmitted for powering theoperation device.

In a preferred embodiment, the method of using a cleaning system forremoving particles comprises the steps of: implanting an implantablesource of energy in the patient, providing an external source of energy,controlling the external source of energy to release wireless energy,charging non-invasively the implantable source of energy with thewireless energy, controlling the implantable source of energy fromoutside the patient's body, and releasing energy for use in connectionwith operation of the cleaning device. The wireless energy is preferablystored in the implantable source of energy.

In another preferred embodiment, the method of using a system forremoving particles comprises the steps of: providing an external sourceof energy outside the patient's body, and controlling the externalsource of energy from outside the patient's body to release wirelessenergy, and using released wireless energy for operating the operationdevice. The wireless energy is preferably transformed into electricalenergy inside the patient's body using an implanted energy-transformingdevice and using the electrical energy when operating the cleaningdevice.

In one embodiment, the electrical energy is used directly in connectionwith operation of the cleaning device, as a transforming devicetransforms the wireless energy into the electrical energy.

In another embodiment, the external source of energy is controlled fromoutside the patient's body to release non-magnetic wireless energy, andreleased non-magnetic wireless energy is used for operating the cleaningdevice.

In yet an alternative embodiment, the external source of energy iscontrolled from outside the patient's body to release electromagneticwireless energy, and released electromagnetic wireless energy is usedfor operating the cleaning device.

The invention also extends to a method for placing a cleaning device,comprising a surgical method via a laparoscopic abdominal approach. Themethod comprises the steps of: inserting a needle or tube likeinstrument into the abdomen of the patient's body, using the needle ortube like instrument to fill the patient's abdomen with gas therebyexpanding the patient's abdominal cavity, placing at least twolaparoscopic trocars in the patient's body, inserting a camera throughone of the trocars into the patient's abdomen, inserting at least onedissecting tool through a trocar and dissecting the intended placementarea of the patient, placing at least one cleaning device in any part ofan implantable drainage device.

Further preferred embodiments are defined by the dependent claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will now be described in more detail by way ofnon-limiting examples and with reference to the accompanying drawings,in which:

FIGS. 1 a and 1 b are views of an implantable drainage device inaccordance with a first embodiment,

FIG. 2 is a view of an implantable drainage device in accordance with asecond embodiment, and

FIG. 3 is a flowchart illustrating different steps performed whenimplanting an implantable drainage device.

FIG. 4 is a sectional view of a cleaning device according to theinvention.

FIG. 5 is a cross sectional view of the cleaning device of FIG. 4 takenalong the line III-III before a cleaning operation.

FIG. 6 is a sectional view of the cleaning device of FIG. 4 taken alongthe line IV-IV.

FIG. 7 is a sectional view similar to that of FIG. 4 showing particlesbefore a cleaning operation.

FIG. 8 is a sectional view similar to that of FIG. 4 during a first stepof a cleaning operation.

FIG. 9 is a sectional view similar to that of FIG. 4 during a secondstep of a cleaning operation.

FIG. 10 is a sectional view similar to that of FIG. 4 during a thirdstep of a cleaning operation.

FIG. 11 is a cross sectional view similar to that of FIG. 5 during acleaning operation.

FIG. 12 is a sectional view of the cleaning device of FIG. 10 takenalong the line X-X showing a cleaning ejection piston before ejection ofparticles.

FIG. 13 is a view similar to that of FIG. 11 but after ejection ofparticles.

FIG. 14 is a schematic diagram of a cleaning system.

FIGS. 15-30 show various embodiments based on the system of FIG. 14.

FIG. 31 is a view of an alternative embodiment of a cleaning system.

FIG. 32 is a general view of an implanted drainage system in a patient.

FIG. 33 is a detailed view of a drainage system.

FIGS. 34 a-34 d are views of exemplary designs of tube ends fordifferent treatment areas.

FIG. 35 is a view of a securing arrangement for securing a tube end in abladder, such as the urine bladder.

FIG. 36 a is a circuit diagram showing an energy transfer amplifier,where the energy is transferred by ultrasonic waves.

FIG. 36 b′, 36 b″ is a circuit diagram showing further anotherembodiment of an amplifier.

FIG. 36 c-d are graphs showing different waveforms of signals in theamplifier of the ultrasonic embodiment.

FIG. 37 is general view of an implanted drainage apparatus with a filterin a patient.

FIG. 38 is a detailed view of a powered filter.

FIGS. 39 a and 39 b are views of a filter cassette.

FIGS. 40 a and 40 b are views of a filter cassette.

DETAILED DESCRIPTION

In FIGS. 1 a and 1 b views illustrating an implantable drainage device100 are shown. The device 100 comprises a bellow 101 adapted to movebetween a compressed position in which the bellow has a small insidevolume and an expanded position in which the bellow has a larger insidevolume. The view in FIG. 1 a shows the bellow in a compressed positionand the view in FIG. 1 b shows the bellow in an expanded position.

The device 100 further comprises a member such as screw 103 adapted tocompress the bellow 101. The screw 103 is accordance with one embodimentdriven by a motor 105. The motor may many type of suitable motorincluding but not limited an electrical motor and a hydraulic motor. Inaccordance with one embodiment the motor is associated with a clutch 107for regulating the power applied to the screw 103.

The inside of the bellow 101 is adapted receive and eject body fluid.The body fluid enters the bellow via an inlet 109 when the bellowexpands. The fluid exits the bellow 101 via an outlet 111 when thebellow is compressed. In order for the fluid to only enter the bellowvia the inlet when the bellow expands, a check valve 113 is provided toprevent fluid to enter via the outlet 111 during the expansion phase.Similarly, the check valve 113 is adapted to prevent fluid to exit viathe inlet 109 when the bellow is compressed. The check valve 113 iscontrolled by a control member 115 such as a solenoid.

The inlet and outlet are shaped to have tubes (not shown) fittedthereon. The tube connected to the inlet is preferably shaped andadapted to be placed in a treatment area from which body fluid is to beremoved. The tube connected to the outlet is preferably shaped andadapted to be placed in a delivery area to which body fluid is to bemoved from the treatment area.

During operation the device is adapted to compress the bellow in acompression phase during which fluid is ejected from the device 100 viathe outlet tube to the delivery area for example by driving the motor todrive the screw. In a preferred embodiment a spring 117 is alsocompressed during the compression phase. During operation the device isfurther adapted to expand the bellow in an expansion phase during whichfluid is sucked into the device 100 via the inlet tube from thetreatment area for example by driving the screw in the oppositedirection. In a preferred embodiment the spring 117 drives the bellow toexpand during the expansion phase. When treating a patient thecompression phase and expansion phase are continuously repeated wherebybody fluid is removed from the treatment area to the delivery area.

In FIG. 2 the device 100 is shown as supplemented with a control unit119 for controlling the operation of the device 100. The control unit119 can receive and transmit signals for a remote unit 121. The unit 121is typically located outside the body when the device 100 is implantedinside a patient. In addition the device can be provided with achargeable power source 123 connected to the motor. The power source 123is adapted to receive wireless power from a second power source 125which typically is located outside the patient when the implantabledevice 100 is implanted in a patient. Hereby the power source 123 can berecharged at suitable time intervals thereby removing the need forreplacing the power source.

In order to prevent or remove a possible occlusion in the tube thedrainage device can be provided with a backward release member 126adapted to generate a backward pressure of fluid or air in the tube forremoving or preventing a possible occlusion in the tube. The backwardpressure is preferably repeatedly according to a predetermined timeschedule. In accordance with one embodiment the release member comprisesa pre-pressurized reservoir of air and a valve adapted to release a puffof air in the tube. In accordance with another embodiment the device 100is adapted to move fluid or air in the tube in the reversed directionthereby creating a reverse flow for prevent or remove a possibleocclusion in the tube. This can for example be obtained by controllingthe check valve 113 to a reversed more of operating so that fluid exitsthe device 100 via the inlet. In accordance with yet another embodimenta reservoir of the drainage is pre-pressurized by the pump, and a valveof the device is adapted to release a puff of fluid or air in the tubeextending from the pre-pressurized reservoir when the pressure hasreached a predetermined level.

In FIG. 3 a flowchart illustrating step performed when implanting thedevice 100 in a patient. First in a step 301 the skin is cut atlocations corresponding to the location where the device is to be placedand where the tubes leading to and from the device are going to beplaced. Next, in a step 303 the area from which body fluid is to beremoved, the treatment area is dissected. Then, in a step 305, the areato which body fluid is to be moved, the delivery area, is dissected.Thereupon, in a step 307, the area where the device is to be placed, theplacement area is dissected, if the placement area is different from thetreatment area and the delivery area. Next, in a step 309 the device isplaced in the placement area and the tubes extending between the deviceand the treatment area and the delivery area are put into place in steps311 and 313, respectively.

In accordance with one embodiment a cleaning device 10 is inserted inthe flow passageway from the treatment area to where the fluid is moved,I.e. the delivery area.

The design of a first preferred embodiment of a cleaning device 10 willnow be described in detail, with reference to FIGS. 4-6. FIG. 4 shows asectional view wherein the cleaning device 10 is provided in the flowpassageway provided by a tube 2 b. A filter 12 is provided across theflow passageway 14 formed in a housing 11 with the function of stoppingparticles brought forward in tube 2 b by the flow, indicated by arrowsin the figure. In this preferred embodiment, the filter 12 comprises aplurality of preferably equally spaced strips 12 a of some suitablematerial, such as biocompatible metal or plastic. These strips 12 a arepreferably arranged mutual parallel.

The distance between two adjacent strips is small enough to stop anyparticles larger than some predetermined size. In accordance with oneembodiment the distance is less than 2 millimeters, and even less than1.0 millimeters. Also for some applications the distance could belarger. The flow passageway 14 can have an essentially squarecross-sectional shape or can it can take any suitable shape, such asrectangular or circular.

By providing a plurality of strips 12 a as a filter across the flowpassageway 14, a laminar flow is achieved downstream of the filter,which is can be advantageous. The flow configuration can be furtherenhanced by giving the plurality of strips 12 a a desiredcross-sectional shape, although the rectangular shape shown in FIG. 6will be adequate for most purposes.

A first piston 16 is provided movable in a direction essentiallyperpendicular to the direction of the flow passageway 14, i.e.,essentially perpendicular to the direction of the flow. This firstpiston 16 is driven by some suitable actuator means, such as pressurizedair, a solenoid arrangement, an electrical servo motor or the like. Amotor could be used to build up a stored power that could be releasedvery fast, one example being a spring. In a preferred embodiment,pressurized air acts as the actuator means, since by latching the pistonby means of a suitable latching means for the piston, building up theair pressure, and subsequently releasing the piston, very high speed ofthe piston is achieved, with enables short cleaning times of the filter.

The outer end portion of the first piston 16, i.e., the end portionfacing the flow passageway 14, is essentially flush with the wall of theflow passageway in a non-active state of the cleaning device 10. Also,the outer end portion is provided with a concave portion or recess 16 a(exaggerated in the figures) in order to act as a particle capturingmeans, as will be explained below.

The strike range of the first piston 16 is preferably such that itextends all way across the flow passageway 14, as will be explainedbelow with reference to FIGS. 7-10. A number of channels 16 bcorresponding to the number of strips 12 a is provided in the firstpiston 16 to accommodate the strips when the first piston is in anextended position.

The first piston 16 is also provided with a plurality of through holes17 in the direction of the flow passageway. These through holes willallow a flow through the flow passageway also during a cleaningoperation, as will be explained below with reference to FIG. 11.

A second piston 18 is provided across the flow passageway 14 from thefirst piston 16. Also this second piston 18 is movable in a directionessentially perpendicular to the direction of the flow passageway 14 andis biased in the direction thereof by means of a spring 18 a, forexample. Likewise, the outer end portion of the second piston isprovided with a recess 18 b similar to the recess 16 a of the firstpiston 16.

The first and second pistons 16, 18, are sealed to the housing 11 bymeans of a respective sealing 20, such as an O sealing.

A preferred embodiment of a cleaning method according to the inventionwill now be described with reference to FIGS. 7-10, showing differentoperational steps of the above-described device. FIG. 7 is a viewsimilar to that of FIG. 4. However, this figure shows the cleaningdevice 10 during operation, wherein particles, generally designated 22,have assembled on the filter 12.

In FIG. 8, the first piston 16 has moved linearly from the retractedstarting position shown FIG. 7 to an extended position, wherein theouter end portion thereof is in contact with the second piston 18. Dueto the recess 16 a in the outer end of the first piston 16, theparticles 22 have been assembled in the recess 16 a, whereby they havebeen brought with the first piston 16 during the movement thereof. Inthe step shown in FIG. 8, the particles are confined in the recess 16 abetween the first and second pistons 16, 18.

By moving the first piston 16 an additional distance from the positionshown in FIG. 8, the second piston 18 is pushed against the force of thespring 18 a to a fully retracted position, see FIG. 9. The plurality ofstrips 12 a is in this position fully received in a respective channel16 b in the first piston. It is seen that the outer ends of the firstand second pistons define an unobstructed cavity in which the particlesare confined. It is thereby possible to remove these by some suitablemeans. One such means could be a third piston 24, which is movable in adirection perpendicular to both the direction of the flow passageway 14and the direction of movement of the first and second pistons 16, 18.This third piston, the movement of which could be controlled by means ofpressurized air, a solenoid, an electric motor etc., scrapes off theparticles collected by the first piston 16 and moves them to a placeoutside of the cleaning device 10 and the flow passageway 14.

FIG. 11 shows a side view of the first piston 16 in a fully extendedposition, i.e., corresponding to the view of FIG. 10. It is here seenthat in this position the through holes 17 will be aligned with the flowpassageway 14, thereby allowing a flow therethrough also during cleaningof the filter 12.

FIG. 12 shows a cross-sectional view taken along line X-X of FIG. 10. Itis here seen that the third piston 24 collects the particles 22 during adownward movement, indicated by an arrow in the figure. The particlesare ejected from the cleaning device 10 when the third piston 24 hasreached its lower end position, shown in FIG. 13.

Again with reference to FIG. 9, it will be realized that pressurized aircan be used for ejecting the collected particles from the cavity formedby the first piston 16 and the second piston 18.

A cleaning system, generally designated 28 and comprising a cleaningdevice as described above will now be described with reference to FIGS.14-26.

A cleaning system is shown in a more generalized block diagram form inFIG. 14, wherein the patient's skin 36, generally shown by a verticalline, separates the interior of the patient to the right of the linefrom the exterior to the left of the line.

FIG. 15 shows an embodiment of the invention identical to that of FIG.14, except that a reversing device in the form of an electric switch 38operable by polarized energy also is implanted in the patient forreversing the cleaning device 10. The wireless remote control of theexternal energy transmission device 34 transmits a wireless signal thatcarries polarized energy and the implanted energy transforming device 30transforms the wireless polarized energy into a polarized current foroperating the electric switch 38. When the polarity of the current isshifted by the implanted energy transforming device 30 the electricswitch 38 reverses the function performed by the cleaning device 10.

FIG. 16 shows an embodiment of the invention identical to that of FIG.14, except that an operation device 40 implanted in the patient forregulating the cleaning device 10 is provided between the implantedenergy transforming device 30 and the cleaning device 10. This operationdevice can be in the form of a motor 40, such as an electric servomotor. The motor 40 is powered with energy from the implanted energytransforming device 30, as the remote control of the external energytransmission device 34 transmits a wireless signal to the receiver ofthe implanted energy transforming device 30.

FIG. 17 shows an embodiment of the invention identical to that of FIG.14, except that it also comprises an operation device is in the form ofan assembly 42 including a motor/pump unit 78 and a fluid reservoir 46is implanted in the patient. In this case the cleaning device 10 ishydraulically operated, i.e. hydraulic fluid is pumped by the motor/pumpunit 44 from the fluid reservoir 46 through a conduit 48 to the cleaningdevice 10 to operate the cleaning device, and hydraulic fluid is pumpedby the motor/pump unit 44 back from the cleaning device 10 to the fluidreservoir 46 to return the cleaning device to a starting position. Theimplanted energy transforming device 30 transforms wireless energy intoa current, for example a polarized current, for powering the motor/pumpunit 44 via an electric power supply line 50.

Instead of a hydraulically operated cleaning device 10, it is alsoenvisaged that the operation device comprises a pneumatic operationdevice. In this case, pressurized air can be used for regulation and thefluid reservoir is replaced by an air chamber and the fluid is replacedby air.

FIG. 18 shows an embodiment of the invention comprising the externalenergy transmission device 34 with its wireless remote control, thecleaning device 10, in this case hydraulically operated, and theimplanted energy transforming device 30, and further comprising ahydraulic fluid reservoir 52, a motor/pump unit 44 and an reversingdevice in the form of a hydraulic valve shifting device 54, allimplanted in the patient. The motor of the motor/pump unit 44 is anelectric motor. In response to a control signal from the wireless remotecontrol of the external energy transmission device 34, the implantedenergy transforming device 30 powers the motor/pump unit 44 with energyfrom the energy carried by the control signal, whereby the motor/pumpunit 44 distributes hydraulic fluid between the hydraulic fluidreservoir 52 and the cleaning device 10. The remote control of theexternal energy transmission device 34 controls the hydraulic valveshifting device 54 to shift the hydraulic fluid flow direction betweenone direction in which the fluid is pumped by the motor/pump unit 44from the hydraulic fluid reservoir 52 to the cleaning device 10 tooperate the cleaning device, and another opposite direction in which thefluid is pumped by the motor/pump unit 44 back from the cleaning device10 to the hydraulic fluid reservoir 52 to return the cleaning device toa starting position.

FIG. 19 shows an embodiment of the invention identical to that of FIG.14, except that an internal control unit 56 controlled by the wirelessremote control of the external energy transmission device 34, anaccumulator 58 and a capacitor 60 also are implanted in the patient. Theinternal control unit 56 arranges storage of electric energy receivedfrom the implanted energy transforming device 30 in the accumulator 58,which supplies energy to the cleaning device 10. In response to acontrol signal from the wireless remote control of the external energytransmission device 34, the internal control unit 56 either releaseselectric energy from the accumulator 58 and transforms the releasedenergy via power lines 62 and 64, or directly transforms electric energyfrom the implanted energy transforming device 30 via a power line 66,the capacitor 60, which stabilizes the electric current, a power line 68and the power line 64, for the operation of the cleaning device 10.

The internal control unit is preferably programmable from outside thepatient's body. In a preferred embodiment, the internal control unit isprogrammed to regulate the cleaning device 10 to remove any particlesfrom the drainage device and place the particles outside the drainagedevice repeatedly according to a pre-programmed time-schedule.

In accordance with an alternative, the capacitor 60 in the embodiment ofFIG. 19 may be omitted. In accordance with another alternative, theaccumulator 58 in this embodiment may be omitted.

FIG. 20 shows an embodiment of the invention identical to that of FIG.14, except that a battery 70 for supplying energy for the operation ofthe cleaning device 10 and an electric switch 72 for switching theoperation of the cleaning device 10 also are implanted in the patient.The electric switch 72 is operated by the energy supplied by theimplanted energy transforming device 30 to switch from an off mode, inwhich the battery 70 is not in use, to an on mode, in which the battery70 supplies energy for the operation of the cleaning device 10.

FIG. 21 shows an embodiment of the invention identical to that of FIG.20, except that an internal control unit 56 controllable by the wirelessremote control of the external energy transmission device 34 also isimplanted in the patient. In this case, the electric switch 72 isoperated by the energy supplied by the implanted energy transformingdevice 30 to switch from an off mode, in which the wireless remotecontrol is prevented from controlling the internal control unit 56 andthe battery is not in use, to a standby mode, in which the remotecontrol is permitted to control the internal control unit 56 to releaseelectric energy from the battery 70 for the operation of the cleaningdevice 10.

FIG. 22 shows an embodiment of the invention identical to that of FIG.21, except that an accumulator 58 is substituted for the battery 70 andthe implanted components are interconnected differently. In this case,the accumulator 58 stores energy from the implanted energy transformingdevice 30. In response to a control signal from the wireless remotecontrol of the external energy transmission device 34, the internalcontrol unit 56 controls the electric switch 72 to switch from an offmode, in which the accumulator 58 is not in use, to an on mode, in whichthe accumulator 58 supplies energy for the operation of the cleaningdevice 10.

FIG. 23 shows an embodiment of the invention identical to that of FIG.22, except that a battery 70 also is implanted in the patient and theimplanted components are interconnected differently. In response to acontrol signal from the wireless remote control of the external energytransmission device 34, the internal control unit 56 controls theaccumulator 58 to deliver energy for operating the electric switch 72 toswitch from an off mode, in which the battery 70 is not in use, to an onmode, in which the battery 70 supplies electric energy for the operationof the cleaning device 10.

Alternatively, the electric switch 72 may be operated by energy suppliedby the accumulator 58 to switch from an off mode, in which the wirelessremote control is prevented from controlling the battery 70 to supplyelectric energy and is not in use, to a standby mode, in which thewireless remote control is permitted to control the battery 70 to supplyelectric energy for the operation of the cleaning device 10.

FIG. 24 shows an embodiment of the invention identical to that of FIG.20, except that a motor 40, a mechanical reversing device in the form ofa gear box 74, and an internal control unit 56 for controlling the gearbox 74 also are implanted in the patient. The internal control unit 56controls the gear box 74 to reverse the function performed by thecleaning device 10 (mechanically operated).

FIG. 25 shows an embodiment of the invention identical to that of FIG.23 except that the implanted components are interconnected differently.Thus, in this case the internal control unit 56 is powered by thebattery 70 when the accumulator 58, suitably a capacitor, activates theelectric switch 72 to switch to an on mode. When the electric switch 72is in its on mode the internal control unit 56 is permitted to controlthe battery 70 to supply, or not supply, energy for the operation of thecleaning device 10.

FIG. 26 schematically shows conceivable combinations of implantedcomponents of the apparatus for achieving various communication options.Basically, there are the cleaning device 10, the internal control unit56, motor/pump unit 44, and the external energy transmission device 34including the external wireless remote control. As already describedabove the wireless remote control transmits a control signal which isreceived by the internal control unit 56, which in turn controls thevarious implanted components of the apparatus.

A feedback device, preferably in the form of a sensor 76, may beimplanted in the patient for sensing a physical parameter of thepatient, such as the pressure in a blood vessel. The internal controlunit 56, or alternatively the external wireless remote control of theexternal energy transmission device 34, may control the cleaning device10 in response to signals from the sensor 76. A transceiver may becombined with the sensor 76 for sending information on the sensedphysical parameter to the external wireless remote control. The wirelessremote control may comprise a signal transmitter or transceiver and theinternal control unit 56 may comprise a signal receiver or transceiver.Alternatively, the wireless remote control may comprise a signalreceiver or transceiver and the internal control unit 56 may comprise asignal transmitter or transceiver. The above transceivers, transmittersand receivers may be used for sending information or data related to thecleaning device 10 from inside the patient's body to the outsidethereof.

Alternatively, the sensor 76 may be arranged to sense a functionalparameter of the cleaning device 10.

Where the motor/pump unit 44 and battery 70 for powering the motor/pumpunit 44 are implanted, the battery 70 may be equipped with a transceiverfor sending information on the condition of the battery 70.

FIG. 27 shows an alternative embodiment wherein the cleaning device 10is regulated from outside the patient's body. The cleaning system 28comprises a cleaning device 10 connected to a battery 70 via asubcutaneous switch 80. Thus, the regulation of the cleaning device 10is performed non-invasively by manually pressing the subcutaneousswitch, whereby the operation of the cleaning device 10 is switched onand off. It will be appreciated that the shown embodiment is asimplification and that additional components, such as an internalcontrol unit, can be added to the cleaning system.

FIG. 28 shows an alternative embodiment, wherein the cleaning system 28comprises a cleaning device 10 in fluid connection with a hydraulicfluid reservoir 52. Non-invasive regulation is performed by manuallypressing the hydraulic reservoir connected to the cleaning device 10.

A further embodiment of a system according to the invention comprises afeedback device for sending information from inside the patient's bodyto the outside thereof to give feedback information related to at leastone functional parameter of the clot removal device or system or aphysical parameter of the patient, thereby optimizing the performance ofthe system.

One preferred functional parameter of the device is correlated to thetransfer of energy for charging the internal energy source.

In FIG. 29, an arrangement is schematically illustrated for supplying anaccurate amount of energy to a cleaning system 28 implanted in apatient, whose skin 36 is indicated by a vertical line. A cleaningdevice 10 is connected to an implanted energy transforming device 30,likewise located inside the patient, preferably just beneath thepatient's skin 36. Generally speaking, the implanted energy transformingdevice 30 may be placed in the abdomen, thorax, muscle fascia (e.g. inthe abdominal wall), subcutaneously, or at any other suitable location.The implanted energy transforming device 30 is adapted to receivewireless energy E transmitted from an external energy source 34 aprovided in the external energy transmission device 34 located outsidethe patient's skin 36 in the vicinity of the implanted energytransforming device 30.

As is well known in the art, the wireless energy E may generally betransferred by means of any suitable Transcutaneous Energy Transfer(TET) device, such as a device including a primary coil arranged in theexternal energy source 34 a and an adjacent secondary coil arranged inthe implanted energy transforming device 30. When an electric current isfed through the primary coil, energy in the form of a voltage is inducedin the secondary coil which can be used to operate a cleaning device,e.g. after storing the incoming energy in an energy storing device oraccumulator, such as a battery or a capacitor. However, the presentinvention is generally not limited to any particular energy transfertechnique, TET devices or energy storing devices, and any kind ofwireless energy may be used. Other energy transfer methods include butare not limited to non-induction methods such as by means of ultra-sonicdevices or using light.

The amount of transferred energy can be regulated by means of anexternal control unit 34 b controlling the external energy source 34 abased on the determined energy balance, as described above. In order totransfer the correct amount of energy, the energy balance and therequired amount of energy can be determined by means of an internalcontrol unit 56 connected to the cleaning device 10. The internalcontrol unit 56 may thus be arranged to receive various measurementsobtained by suitable sensors or the like, not shown, measuring certaincharacteristics of the cleaning device 10, reflecting the requiredamount of energy needed for proper operation of the cleaning device 10.Moreover, the current condition of the patient may also be detected bymeans of suitable measuring devices or sensors, in order to provideparameters reflecting the patient's condition. Hence, suchcharacteristics and/or parameters may be related to the current state ofthe cleaning device 10, such as power consumption, operational mode andtemperature, as well as the patient's condition reflected by, e.g., bodytemperature, blood pressure, heartbeats and breathing.

Furthermore, an energy storing device or accumulator 58 may optionallybe connected to the implanted energy transforming device 30 foraccumulating received energy for later use by the cleaning device 10.Alternatively or additionally, characteristics of such an accumulator,also reflecting the required amount of energy, may be measured as well.The accumulator may be replaced by a battery, and the measuredcharacteristics may be related to the current state of the battery, suchas voltage, temperature, etc. In order to provide sufficient voltage andcurrent to the cleaning device 10, and also to avoid excessive heating,it is clearly understood that the battery should be charged optimally byreceiving a correct amount of energy from the implanted energytransforming device 30, i.e. not too little or too much. The accumulatormay also be a capacitor with corresponding characteristics.

For example, battery characteristics may be measured on a regular basisto determine the current state of the battery, which then may be storedas state information in a suitable storage means in the internal controlunit 56. Thus, whenever new measurements are made, the stored batterystate information can be updated accordingly. In this way, the state ofthe battery can be “calibrated” by transferring a correct amount ofenergy, so as to maintain the battery in an optimal condition.

Thus, the internal control unit 56 is adapted to determine the energybalance and/or the currently required amount of energy, (either energyper time unit or accumulated energy) based on measurements made by theabove-mentioned sensors or measuring devices on the cleaning device 10,or the patient, or an energy storing device if used, or any combinationthereof. The internal control unit 56 is further connected to aninternal signal transmitter 82, arranged to transmit a control signalreflecting the determined required amount of energy, to an externalsignal receiver 34 c connected to the external control unit 34 b. Theamount of energy transmitted from the external energy source 34 a maythen be regulated in response to the received control signal.

Alternatively, sensor measurements can be transmitted directly to theexternal control unit 34 b wherein the energy balance and/or thecurrently required amount of energy can be determined by the externalcontrol unit 34 b, thus integrating the above-described function of theinternal control unit 56 in the external control unit 34 b. In thatcase, the internal control unit 56 can be omitted and the sensormeasurements are supplied directly to the internal signal transmitter 82which sends the measurements over to the external signal receiver 34 cand the external control unit 34 b. The energy balance and the currentlyrequired amount of energy can then be determined by the external controlunit 34 b based on those sensor measurements.

Hence, feedback of information indicating the required energy can beused, which is more efficient because it is based on the actual use ofenergy that is compared to for example the received energy, e.g. withrespect to the amount of energy, the energy difference, or the energyreceiving rate as compared to the energy rate used by the cleaningdevice. The cleaning device may use the received energy either forconsuming or for storing the energy in an energy storage device or thelike. The different parameters discussed above would thus be used ifrelevant and needed and then as a tool for determining the actual energybalance. However, such parameters may also be needed per se for anyactions taken internally to specifically operate the clot removaldevice.

The internal signal transmitter 82 and the external signal receiver 34 cmay be implemented as separate units using suitable signal transfermeans, such as radio, IR (Infrared) or ultrasonic signals.Alternatively, the internal signal transmitter 82 and the externalsignal receiver 34 c may be integrated in the implanted energytransforming device 30 and the external energy source 34 a,respectively, so as to convey control signals in a reverse directionrelative to the energy transfer, basically using the same transmissiontechnique. The control signals may be modulated with respect tofrequency, phase or amplitude.

The energy supply arrangement illustrated in FIG. 29 may operatebasically in the following manner. The energy balance is firstdetermined by the internal control unit 56. A control signal reflectingthe required amount of energy is also created by the internal controlunit 56, and the control signal is transmitted from the internal signaltransmitter 82 to the external signal receiver 34 c. Alternatively, theenergy balance can be determined by the external control unit 34 binstead depending on the implementation, as mentioned above. In thatcase, the control signal may carry measurement results from varioussensors. The amount of energy emitted from the external energy source 34a can then be regulated by the external control unit 34 b, based on thedetermined energy balance, e.g. in response to the received controlsignal. This process may be repeated intermittently at certain intervalsduring ongoing energy transfer, or may be executed on a more or lesscontinuous basis during the energy transfer.

The amount of transferred energy can generally be regulated by adjustingvarious transmission parameters in the external energy source 34 a, suchas voltage, current, amplitude, wave frequency and pulsecharacteristics.

A method is thus provided for controlling transmission of wirelessenergy supplied to an electrically operable cleaning device implanted ina patient. The wireless energy E is transmitted from an external energysource located outside the patient and is received by an internal energyreceiver located inside the patient, the internal energy receiver beingconnected to the clot removal device for directly or indirectlysupplying received energy thereto. An energy balance is determinedbetween the energy received by the internal energy receiver and theenergy used for the cleaning device. The transmission of wireless energyE from the external energy source is then controlled based on thedetermined energy balance.

A system is also provided for controlling transmission of wirelessenergy supplied to an electrically operable cleaning device implanted ina patient. The system is adapted to transmit the wireless energy E froman external energy source located outside the patient which is receivedby an implanted energy transforming device located inside the patient,the implanted energy transforming device being connected to the cleaningdevice for directly or indirectly supplying received energy thereto. Thesystem is further adapted to determine an energy balance between theenergy received by the implanted energy transforming device and theenergy used for the cleaning device, and control the transmission ofwireless energy E from the external energy source, based on thedetermined energy balance.

The functional parameter of the device is correlated to the transfer ofenergy for charging the internal energy source.

In yet an alternative embodiment, the external source of energy iscontrolled from outside the patient's body to release electromagneticwireless energy, and released electromagnetic wireless energy is usedfor operating the cleaning device.

In another embodiment, the external source of energy is controlling fromoutside the patient's body to release non-magnetic wireless energy, andreleased non-magnetic wireless energy is used for operating the cleaningdevice.

Those skilled in the art will realize that the above various embodimentsaccording to FIGS. 14-30 could be combined in many different ways. Forexample, the electric switch 38 operated polarized energy could beincorporated in any of the embodiments of FIGS. 16, 19-25, the hydraulicvalve shifting device 54 could be incorporated in the embodiment of FIG.17, and the gear box 74 could be incorporated in the embodiment of FIG.16.

Wireless transfer of energy for operating the cleaning device has beendescribed to enable non-invasive operation. It will be appreciated thatthe cleaning device can be operated with wire bound energy as well. Onesuch example is shown in FIG. 30, wherein an external switch 84 isinterconnected between the external energy source 34 a and an operationdevice, such as an electric motor regulating the cleaning device 10, bymeans of power lines 86 and 88. An external control unit 34 b controlsthe operation of the external switch to effect proper operation of thecleaning device 10.

Also other filters can be used in the cleaning device 10. One suchfilter is depicted in FIG. 31. The filter 90 in FIG. 31 comprises arotating member 91 located in the flow passage way of the drainagedevice. The rotating member can be formed by a number of segments 92.Particles in the flow will caught by the segments and moved to the rimof the rotating member 91 where the particles can be effectively removedfrom the flow pathway of the drainage device. The cleaning device inFIG. 31 can be powered in the same manner as the cleaning devicedescribed above.

In FIG. 32 a general view of a patient having an implanted drainagesystem as described herein. The system comprises a first end of thedrainage system located in a treatment area 1. The system furthercomprises a pump 100 adapted to move fluid from the treatment area 1 toa delivery area 3. The treatment area can be any area from which fluidis to be move including but not limited to the abdomen, the lungs andthe brain. Similarly the delivery area can be any suitable delivery areawithin the body, including but not limited to the Urine bladder and thestomach.

The pump can be powered by an energy source 123 as described above. Theenergy source can be energized from outside the patient using a wirelessenergy transfer device. The energy transfer device can transfer energyin a way suitable such as by inductive energy using coils or ultra sonicenergy transfer or by transmitting light through the skin of thepatient. Also the fluid passageway from the treatment area to thedelivery area can comprise a cleaning device 10 as described above. Thecleaning device can in one embodiment be powered by a motor and themotor can then be supplied with energy from the energy source 123.

In FIG. 33 the drainage system is shown in more detail. The view in FIG.33 corresponds to the view in FIG. 32. However instead of showing thetreatment areal, FIG. 33 shows and end member 4 of the tube located inthe treatment area. As described above the end member 4 can be designeddifferently for different treatment areas. Different end members aredescribed in more detail below.

In FIGS. 34 a-34 d different exemplary designs of end members 4 areshown in more detail. Thus, a connecting tube for use in an implantabledrainage device being adapted to move body fluid from one part of thebody, herein termed treatment area, of a human or mammal patient isprovided. A distal end of the connecting tube comprises in accordancewith one embodiment a portion having a flat shape. Such an end portioncan advantageously be used in the lungs when moving fluid from thelungs. The end portion can have an essential circular shape as is shownin FIG. 34 a or have a polygonal shape as is shown in FIG. 34 b.

In accordance with one embodiment the distal end of the connecting tubecan comprises a portion having a generally cylindrical shape as is shownin FIG. 34 c. Such a shape can be preferred in applications where thereis a risk that the tube end is sucked towards the wall of the treatmentarea. In FIG. 34 d yet another embodiment is shown with a very flexibletube end that can be used as a versatile tube in that it combinesadvantages of a flat tube end and a cylindrical tube end at the expenseof the disadvantages of being flexible.

The tube ends are provided with holes or formed by a netlike structure.The diameter of the hole can in accordance with one embodiment be in therange of 1-10 mm. The number of holes and the diameter can typicallydepend on the treatment. As a general rule more holes and larger holeswill give a lower sucking force and vice versa. Thus, areas where a lowsucking force is required such as in the lungs can be treated using atube end having many and large holes in the tube end.

In FIG. 35 a securing arrangement for securing a second end of a tube ofthe drainage device into the urine bladder is depicted. The arrangementcomprises a tube end placed in the urine bladder 3 through a hole madein the wall of the urine bladder. On the outside the tube is led througha tunnel 95 formed by folding the outside wall of the urine bladderaround the tube. The tunnel is secured around the tube by sutures 97 orsimilar. At the end of the tunnel a net structure 96 is tightly securedto the tube. The net structure has small diameter typically smaller than0.5 mm. In any event the net structure has holes that will be smallenough to be overgrown by tissue thereby providing a tight sealing sothat no leakage occur. As stated above energy can be transferred indifferent manners from outside a patient into a implanted drain asdescribed herein. In particular the energy can be transferred by meansof an inductive energy transfer or by transmission using an ultrasonicenergy transmission, or by transmission of energy using light.

FIG. 36 a illustrates a triangle wave generator circuit, the output ofwhich is connected as an input terminal of an amplifier used fortransmitting energy using an ultrasonic energy transmission. In FIGS. 36a and 36 b′, 36 b″ the symbols Y1, Y2, Y3 and so on symbolize testpoints within the circuit. The components in the circuit diagrams andtheir respective values are values that work in this particularimplementation which of course is only one of an infinite number ofpossible design solutions.

FIG. 36 a shows a circuit diagram containing most of an exemplaryamplifier, in the lower left corner of FIG. 36 a there is the LF inputwhich is the input for the 25 kHz sine wave that should be amplifiedinto a digital output signal. The LF-input there is the triangle waveinput emanating from the Triangle schematic. To the right in the middlein the Core schematic there is the transmitting crystal, X4, connectedto the differential digital outputs, positive and negative output, ofthe amplifier. The transmitting crystal X4 is in series with itsassociated tuning circuit components tuned to the sending frequency,which in this particular case is 25 kHz. FIGS. 36 c-36 d displays therelationship between the input and the output signal of the amplifier,in FIG. 36 c Y25 is the input signal and Y2 is the positive digitaloutput signal from the amplifier and in FIG. 36 d Y13 is the negativedigital output from the amplifier.

As described above the implanted drainage device can be powered by aninternal power supply. The same power supply or another power supply canbe used to provide energy the filter and or cleaning device 10 asdescribed herein. In FIG. 37 a general view similar to the view in FIG.32 is shown where the filter and the cleaning device 10 is connected toa power supply. The apparatus in FIG. 37 comprises a first end of thedrainage apparatus located in a treatment area 1. The apparatus furthercomprises a pump 100 adapted to move fluid from the treatment area 1 toa delivery area 3. The treatment area can be any area from which fluidis to be move including but not limited to the abdomen, the lungs andthe brain. Similarly the delivery area can be any suitable delivery areawithin the body, including but not limited to the Urine bladder and thestomach. The apparatus can as stated above further comprise a filter andor a cleaning device 10. The filter and or cleaning device 10 can bepowered by an energy source 123 a as described above. The energy sourcecan be the same as the energy source 123 powering a pump, but can alsobe another energy source. The energy source 123 a can be energized fromoutside the patient using a wireless energy transfer device. The energytransfer device can transfer energy in a way suitable such as byinductive energy using coils or ultra sonic energy transfer or bytransmitting light through the skin of the patient. Also the fluidpassageway from the treatment area to the delivery area can comprise acleaning device 10 as described above. The cleaning device can in oneembodiment be powered by a motor and the motor can then be supplied withenergy from the energy source 123 a.

In FIG. 38 the power supply to a filter and a cleaning device 10 isshown in more detail. The view in FIG. 38 corresponds to the view inFIG. 37. However instead of showing the treatment area 1, FIG. 38 showsand end member 4 of the tube located in the treatment area. As is shownin FIG. 38 the energy source 123 and 123 a can be energized from outsidethe skin 5 of a patient by an external energy source 6. The energysource can also receive and transmit information to and from an externalsignaling device 7. The cleaning device can also be connected tochangeable filter cassettes 127. In accordance with one embodiment adirty filter of a cassette 127 is adapted to be replaced by a new filterof the cassette. The filter can also comprise a net structure.

In FIG. 39 a a cassette 127 for holding filters is shown. The cassette27 comprises a revolving cylinder 129 having segments 130 each holding afilter. The cylinder 129 is tightly sealed between two supports 131holding the cylinder 129 in place and providing a tight sealing. Thefluid passage way of an implantable drainage apparatus passes throughthe cassette 127. The cassette is driven by a motor 133 causing thecylinder 129 to revolve at suitable times. The motor is powered by apower supply 123 b. The power supply can be a power supply like thepower supplies 123 or 123 a. In accordance with one embodiment the powersupplies 123, 123 a and 123 b is the one and same power supply. As withthe power supplies 123 and 123 a, the power supply 123 b can receivewireless energy in a suitable form, including but not limited toinductive energy ultrasonic energy, light energy or any other form ofwireless energy set out above. The energy is supplied by an externalwireless energy transmitter 6 adapted to transmit energy through theskin 5 of a patient having the cassette 127 implanted. The power supply132 b can also comprise a control unit as described above forcontrolling the revolving cassette 127. The control unit can providefeedback to the outside and receive input data from an externaltransceiver 7 in a manner similar to the control unit used inconjunction with control of the pump.

In FIG. 39 b the cassette 127 is shown from the side with the supports131 and the revolving cylinder spaced apart is a disassembled view.

In FIG. 40 a an alternative embodiment of the cassette 127 is shown. Theview in FIG. 39 a is similar to the view in FIG. 39 a. In the embodimentin FIG. 40 a a magazine 135 having a number of cylinders 129 storedtherein is provided. Hereby a cylinder 129 can by replaced by shiftingthe cylinders in the magazine 135. In one embodiment the cylinders areshifted by pressurized air.

In FIG. 40 b the cassette 127 is shown from the side with the supports131 and the revolving cylinder spaced apart is a disassembled view.

Please note that any embodiment or part of embodiment or feature ormethod or associated system or part of system described herein may becombined in any combination.

The invention claimed is:
 1. An apparatus adapted for drainage of a bodyfluid in a body of a patient who is a human or a mammal patient,comprising: a drainage device, an energy source adapted to supply energyto said drainage device, and at least one connecting tube connected tosaid drainage device, the drainage device and the at least oneconnecting tube forming a drainage arrangement, wherein the drainagearrangement is adapted to be implanted inside the body of the patient,and wherein said at least one connecting tube is adapted tointerconnects a first part of the body with a second part of the bodyand said drainage device is adapted to suck body fluid from the firstpart of the body via the at least one connecting tube to the second partof the body, wherein the drainage device comprises an expandingreservoir comprising: a pre-tensioned bellows adapted to generate asuction and having an inlet with an inlet check valve and an outlet withan outlet return valve, a member adapted to move the pre-tensionedbellows to expand to suck fluid, and a motor adapted to compress thepre-tensioned bellows and move fluid out of the pre-tensioned bellows,wherein said drainage device is adapted to repeat sucking and moving offluid, wherein said drainage device is adapted to constantly suck fluidusing a pre-tensioned load on the pre-tensioned bellows when not movingfluid to the second part of the body, and wherein the apparatus adaptedfor drainage of a body fluid in a patient further comprises; an internalcontrol unit and a sensor, wherein the apparatus adapted for drainage ofa body fluid in a patient is further adapted to send information fromthe sensor to the internal control unit to give feedback related to atleast one of a functional parameter of the drainage device and aphysical parameter of the patient, the internal control unit adapted toact in response to the information to regulate said drainage device (i)to compress the pre-tensioned bellows, and repeatedly move fluid out ofthe pre-tensioned bellows and (i) to control when to constantly suckfluid using the pre-tensioned load on the pre-tensioned bellows, whilemoving fluid to the second part of the body is stopped.
 2. The apparatusfor drainage of a body fluid in a patient according to claim 1, whereinthe at least one connecting tube is adapted to have a size, shape andconfiguration adapted to a specific treatment area of the first and/orthe second part of the body.
 3. The apparatus for drainage of a bodyfluid in a patient according to claim 1, wherein said pre-tensioned loadcomprises a spring loaded by a motor.
 4. The apparatus for drainage of abody fluid in a patient according to claim 1, further comprising asecond tube in a delivery area connected to the outlet of thepre-tensioned bellows for conveying fluid to the second part of thebody.
 5. The apparatus for drainage of a body fluid in a patientaccording to claim 4, wherein the second tube in the delivery area isprovided with a net structure sealed around the second tube.
 6. Theapparatus for drainage of a body fluid in a patient according to claim4, wherein the net structure is provided with holes having a diameteradapted to be overgrown by tissue.
 7. The apparatus for drainage of abody fluid in a patient according to claim 3, wherein said pre-tensionedbellows, having the pre-tensioned load comprising said spring being apassive spring, the apparatus for drainage of a body fluid in a human ormammal patient being adapted to move the pre-tensioned bellows to expandto suck from the inlet, wherein the motor is adapted to compress thebellow and move fluid out from the outlet and thereby pre-tensioningsaid spring, said drainage device further being adapted to repeatsucking and moving of fluid to constantly suck fluid when not movingfluid to the second part of the body.
 8. The apparatus for drainage of abody fluid in a patient according to claim 1, wherein the energy sourcecomprises an internal energy source and an external energy sourcetransmitting wireless energy, and wherein said apparatus for drainage ofa body fluid in a human or mammal patient further comprises an energytransmitter transmitting wireless energy from the external energy sourceto charge said internal energy source, and wherein the apparatus fordrainage of a body fluid in a human or mammal patient is further adaptedto send feedback information from inside the body to outside thereof togive feedback related to any functional parameter of the drainage deviceor the physical parameter of the patient relating to the charge of saidinternal energy source.
 9. The apparatus for drainage of a body fluid ina patient according to claim 1, wherein the functional parameter of thedevice is correlated to a transfer of energy for charging the internalenergy source.
 10. The apparatus for drainage of a body fluid in apatient according to claim 8, adapted to receive transmitted wirelessultra sonic, inductive, or light energy.
 11. The apparatus for drainageof a body fluid in a human or mammal patient according to claim 8,further comprising a feedback device adapted to transmit at least twodifferent types of feedback information.
 12. The apparatus for drainageof a body fluid in a patient according to claim 1, comprising a backwardrelease member adapted to generate a backward pressure of fluid or airin the at least one connecting tube adapted for removing or preventingan occlusion in the at least one connecting tube.
 13. The apparatus fordrainage of a body fluid in patient according to claim 12, wherein saidbackward release member comprises a pre-pressurized reservoir of air anda valve adapted to release a puff of air in the at least one connectingtube.
 14. The apparatus for drainage of a body fluid in a patientaccording to claim 12, comprising a pump adapted to move fluid or air inthe at least one connecting tube in a reversed direction.
 15. Theapparatus for drainage of a body fluid in a human or mammal patientaccording to claim 14, further comprising a reservoir, said reservoirbeing pre-pressurized by said pump, the apparatus for drainage of a bodyfluid in a human or mammal patient further comprising a valve adapted torelease a puff of fluid or air in the at least one connecting tubeextending from the pre-pressurized reservoir when a pressure has reacheda predetermined level.
 16. The apparatus for drainage of a body fluid ina patient according to claim 1, further comprising a wireless remotecontrol, wherein the drainage device is adapted to non-invasively haveany of its functions regulated by said wireless remote control.
 17. Theapparatus for drainage of a body fluid in a patient according to claim1, comprising a wireless energy transmitter, wherein the drainage deviceis adapted to non-invasively have any of its functions regulated by saidwireless energy transmitter.
 18. The apparatus for drainage of a bodyfluid in a patient according to claim 1, further comprising a sensorsensing the physical parameter of the patient.
 19. The apparatus fordrainage of a body fluid in a patient according to claim 1, furthercomprising a sensor sensing the functional parameter of the drainagedevice.